Phase III ALPINE study of Aristada + Invega Sustenna meets endpoint in schizophrenia

Alkermes announced positive topline results from the phase III ALPINE, a first-of-its-kind, six-month study evaluating the efficacy, safety and tolerability of Aristada (aripiprazole lauroxil) and Invega Sustenna (paliperidone palmitate) when used to initiate patients experiencing an acute exacerbation of schizophrenia in the hospital and maintain treatment in an outpatient setting. Patients randomized to the Aristada treatment group were initiated using the Aristada Inition regimen followed by Aristada (1064 mg) every two months. Patients randomized to the Invega Sustenna treatment group were initiated using a loading dose of Invega Sustenna (234 mg) followed by Invega Sustenna (156 mg) every month.

The ALPINE study met its pre-specified primary endpoint, demonstrating that both Aristada and Invega Sustenna had statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale (PANSS) total scores from baseline at Week 4 (Aristada group: -17.4 points, p<0.001; Invega Sustenna group: -20.1 points, p<0.001). Additionally, PANSS total scores continued to improve at Week 9 and Week 25, the study's pre-specified secondary endpoints (Aristada group: -19.8 points, p<0.001 at Week 9 and -23.3 points, p<0.001 at Week 25 Invega Sustenna group: -22.5 points, p<0.001 at Week 9 and -21.7 points, p<0.001 at Week 25). Improvements in PANSS total scores from baseline were similar and not statistically different between treatment groups at any assessment time point during the study.

The most common adverse events reported in the Aristada treatment group were injection site pain (17.2%), increase in weight (9.1%) and akathisia (9.1%). The most common adverse events reported in Invega Sustenna treatment group were injection site pain (24.8%), increase in weight (16.8%) and akathisia (10.9%). Overall, 56.6% of patients in the Aristada treatment group and 42.6% of patients in the Invega Sustenna treatment group completed the six-month study. Alkermes expects to submit results from the ALPINE study to peer-reviewed journals for publication and present full study results, including efficacy, safety, tolerability and exploratory analyses, at upcoming scientific meetings.